Trial Outcomes & Findings for Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression- (NCT NCT01166724)

Results Overview

The primary analyses will compare biopsy-derived measures of fibrosis in the Tac-maintenance and SRL groups using the t-test.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

12 participants

Primary outcome timeframe

12 months

Results posted on

2017-06-07

Participant Flow

Participant milestones

Participant milestones
Measure	Sirolimus patients will be switched from Tacrolimus to Sirolimus Sirolumus: Tacrolimus to Sirolimus Tacrolimus: dosage per trough level	Tacrolimus Patient will stay on Tacrolimus
Overall Study STARTED	7	5
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sirolimus n=7 Participants patients will be switched from Tacrolimus to Sirolimus Sirolumus: Tacrolimus to Sirolimus Tacrolimus: dosage per trough level	Tacrolimus n=5 Participants Patient will stay on Tacrolimus	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=7 Participants	5 Participants n=5 Participants	11 Participants n=12 Participants
Age, Categorical >=65 years	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=12 Participants
Sex: Female, Male Female	2 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=12 Participants
Sex: Female, Male Male	5 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=12 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 12 months

Population: Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.

The primary analyses will compare biopsy-derived measures of fibrosis in the Tac-maintenance and SRL groups using the t-test.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: Early termination; Sponsor discontinued the study for corporate reasons. No data analyzed. Data were not collected and the outcome measure was not analyzed.

We will also compare the change in iGFR (as well as estimated GFR) from time of conversion to 12 and 24 months of follow up by paired t-test between groups.

Outcome measures

Outcome data not reported

Adverse Events

Sirolimus

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Tacrolimus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Sirolimus n=7 participants at risk patients will be switched from Tacrolimus to Sirolimus Sirolumus: Tacrolimus to Sirolimus Tacrolimus: dosage per trough level	Tacrolimus n=5 participants at risk Patient will stay on Tacrolimus
Endocrine disorders Pruritus; Pancreatitis	14.3% 1/7	0.00% 0/5
General disorders ER Admit: Fever, Vomitting	14.3% 1/7	0.00% 0/5

Other adverse events

Other adverse events
Measure	Sirolimus n=7 participants at risk patients will be switched from Tacrolimus to Sirolimus Sirolumus: Tacrolimus to Sirolimus Tacrolimus: dosage per trough level	Tacrolimus n=5 participants at risk Patient will stay on Tacrolimus
General disorders ER Admit: Fever, Vomitting	14.3% 1/7	0.00% 0/5
Gastrointestinal disorders Food Poisoning	14.3% 1/7	0.00% 0/5
Metabolism and nutrition disorders Dehydration	14.3% 1/7	0.00% 0/5
General disorders Fever, Cough	14.3% 1/7	0.00% 0/5

Additional Information

Dr. Stuart Flechner

Cleveland Clinic

Phone: 216 445-5772

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place